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Home » Authors » Randy Osborne

Randy Osborne

Articles

ARTICLES

Don't fence me out: Trials in lung cancer should ease sign-up criteria, study says

June 4, 2019
By Randy Osborne
CHICAGO – Problems for researchers in enrolling lung cancer studies, as well as the woes felt by patients trying to gain entry so they can try prospective new drugs, could largely go away if investigators adopt eligibility criteria backed by work detailed at the American Society of Clinical Oncology (ASCO) meeting.
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On the EVe of big change in urothelial, Seagen ADC nets response rate of 44%

June 4, 2019
By Randy Osborne
CHICAGO – Seattle Genetics Inc. (Seagen) and Tokyo-based partner Astellas Pharma Inc. saw their antibody-drug conjugate (ADC) enfortumab vedotin (EV) highlighted at the American Society of Clinical Oncology (ASCO) annual meeting by way of the abstract for data from a single-arm phase II trial in 125 patients with locally advanced or metastatic urothelial cancer.
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Lung story short: Merck's Keytruda guts, glory story offers hope on two fronts

June 4, 2019
By Randy Osborne
CHICAGO – Merck & Co. Inc.'s Keytruda (pembrolizumab) gained still more laurels at the American Society of Clinical Oncology (ASCO) meeting, where attendees learned of two victorious experiments with the anti-PD-1 immunotherapy.
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Keep Kalm and Cara on: Second phase III data due later this year, then NDA submission

May 30, 2019
By Randy Osborne
"We're running as fast as we can to look at other populations," said Cara Therapeutics Inc. CEO Derek Chalmers after the company disclosed positive top-line data from the pivotal phase III trial called Kalm-1 with Korsuva (CR-845/difelikefalin) for injection in hemodialysis (HD) patients with moderate to severe chronic kidney disease (CKD)-associated pruritus (CKD-aP).
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Going all the way, NMDA work sped up as chances weighed for big players

May 24, 2019
By Randy Osborne
Word from the FDA to Axsome Therapeutics Inc. about the effort with its oral N-methyl-D-aspartate (NMDA) receptor antagonist, AXS-05, in depression – and the company's accelerated push with the compound – had Wall Street watching the NMDA space with even more interest than usual.
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Sampler times ahead: HAE oral bid by Biocryst brings 'flexible' try-it-on-us ploy

May 22, 2019
By Randy Osborne
With efficacy that hit the primary endpoint but fell below what Wall Street watched for, Biocryst Pharmaceuticals Inc. hopes a sampling program and BCX-7353's oral route will help gain market share for the once-daily kallikrein inhibitor to prevent hereditary angioedema (HAE).
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Rinri 'stems' hearing loss, $1.7M seed round to fund effort from U of Sheffield

May 21, 2019
By Randy Osborne
"This is just a tiny seed round," Detlev Mennerich, of Boehringer Ingelheim Venture Fund (BIVF), conceded, telling BioWorld however that backers of Rinri Therapeutics Ltd. "have a clear vision" how the firm can use its newly banked £1.4 million (US$1.7 million) to develop chemistry, manufacturing and controls before going back to the market in a year or so for "north of $10 million" in series A money and then taking aim at phase Ib/IIa work.
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Troponin proponents still, analysts like Cytokinetics' reldesemtiv odds in ALS

May 20, 2019
By Randy Osborne
Cytokinetics Inc. CEO Robert Blum said it's "highly unlikely" that the phase III trial planned with fast skeletal muscle troponin activator reldesemtiv, also known as CK-2127107, will begin this year, "just knowing what the tasks in front of us are." But the South San Francisco-based firm, with partner Astellas Inc., of Tokyo, is moving ahead with the candidate in amyotrophic lateral sclerosis (ALS) despite results from the Fortitude-ALS trial showing that the drug missed statistical significance for the primary efficacy analysis after 12 weeks of treatment.
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Abstract painter: ASCO's KRAS rollouts red Haring? Early brushwork pleases

May 17, 2019
By Randy Osborne
With abstracts presaging the customary avalanche of data due from the American Society of Clinical Oncology (ASCO) meeting next month, the mechanism of KRAS inhibition caused an expectedly large share of talk, though efforts remain far from mature, and too fresh for big conclusions.
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Kymera's era: Vertex deal makes degrade, up to $1B+ as Pegasus springs flowing

May 15, 2019
By Randy Osborne

Kymera Therapeutics Inc. CEO Laurent Audoly told BioWorld that his firm's deal with Vertex Pharmaceuticals Inc. "signals to the sector how protein degradation is broadly deployable across many diseases. We're going way beyond oncology and immunology."


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